Last Friday, the FDA said in new guidance that it would provide a one-year stabilization period for certain provisions of the Drug Supply Chain Security Act, toward a final deadline of November 27, 2024. The move is meant to allow enough time for trading partners at all levels to resolve any remaining "technical and operational issues" that might stand in the way of fully interoperable data exchange.
It's essential for pharmacies to keep their responsibilities in sight. And not just the ones that go into force in 2024; the ones they're required to meet now.
DSCSA is designed to bring about greater patient safety in the U.S. by making all products fully traceable, and by requiring data with every product exchange. This allows instantaneous reactions to recalls, immediate recognition of diverted or dangerous products, and confirmation that each transaction is legitimate.
Here's a quick look at functions your pharmacy must be able to perform under the DSCSA provisions that are already in place today.
Pharmacies must only conduct business with authorized trading partners, such as properly licensed and registered wholesalers permitted to ship in your state. So, lacking this status can directly keep a pharma business from operating. It's important to maintain the federal and state licenses of suppliers and customers, and also to keep trading partners updated on your own licenses.
As ATPs, wholesale distributors must accept or transfer direct ownership of a product from or to a manufacturer, repackager, a dispenser, or another wholesale distributor. They should also have a valid license under Sections 582 and 583 of the Food, Drug, and Cosmetic Act, comply with reporting requirements under Section 503(e), and follow any state licensing laws.
Manufacturers must either manufacture a product, be the approved application holder, or a co-licensed partner or affiliate, obtaining the product directly. A manufacturer must have valid registration in accordance with section 510 of the Food, Drug, and Cosmetic Act, and comply with all applicable obligations of the Act. Manufacturers who distribute their own products don't need to meet licensure requirements for wholesale distributors.
Pharmacies need to be able to receive, store, and share product tracing information at the lot level, and can only accept prescription drugs that are sent with correct T3 data (Transaction Information, Transaction History, and Transaction Statement).
The previously accepted standard for electronic product tracing was EDI 856 Advanced Shipping Notice (ASN); the industry is now increasingly adopting GS1’s Electronic Product Code Information Services (EPCIS), which provides a complete product event history, from manufacture to final sale. Trading partners must return shipments that arrive without an electronic product tracing document.
Pharmacies must establish procedures to investigate and properly handle suspect or illegitimate drugs, toward keeping dangerous products from reaching patients or entering the supply chain, and helping identify any situations where the public may be in danger.
Their responsibilities include:
This serves one of the core functions of DSCSA: safeguarding the public. Developing strong procedures for product investigations is both an immediate need and a way to protect your business from time-consuming, confusing, and even antagonistic situations.
LSPedia's OneScan Pharmacy Pro is the leading DSCSA compliance solution for pharmacies, giving them the power to easily track and update Authorized Trading Partners, receive lot-level ASN and EPCIS files, coordinate product investigations with trading partners, and more.
Business of any size, from local independent pharmacies to chains, can easily implement DSCSA without replacing any systems. OneScan Pharmacy Pro’s elegant cloud design lets it work seamlessly with any dispensing or pharmacy management software; integrations are fast and effective, and teams can get started rapidly via an intuitive, easy-to-use interface.
The solution also goes beyond compliance, optimizing supply chain operations to bring down costs — so that, beyond avoiding expensive pitfalls, OneScan Pharmacy Pro makes DSCSA a chance for dispensers to boost efficiency and save money.
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